STUDY MULTICENTRIC PILOT OF CHEMOTHERAPY WITH CAPECITABINE, OXALIPLATIN LOHP IRINOTECAN Cpt-11 IN PATIENTS WITH Colorectal METASTATIC cancer - XELOXIRI

• Conditions: Patients with metastatic colon-rectal cancer; MedDRA version: 6.1Level: PTClassification code 10052358

• Registration Number: EUCTR2005-005846-37-IT
• Lead Sponsor: G.O.N.O. Gruppo Oncologico del Nord Ovest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

-Istologic diagnosis of adenocarcinoma of the colon or the rectum - measurable metastatic Disease second criteria RECIST - not resecabile metastatic Disease -Age 18 years and 75 years - ECOG performance status 2 for patients of age 70 years - ECOG performance status for patients of 0 ages comprised between 71 and 75 years - Attended of advanced life to 3 months - Adapted renal functionality creatininemia 1,25 x VN - hepatic functionality bilirubinemia 1,5 mg/dl, fosfata alkaline, SGOT and SGPT 2,5 x VN in case of hepatic metastases fosfata alkaline, SGOT and SGPT 5 x VN - Adapted medullary functionality emoglobina 10 g/dl, neutrophil 2,0 x 109/L, piastrine 150 x 109/L - adjuvant Chemotherapy with fluoropirimidine or inhibitors of the timidilato sintetasi raltitrexed finished gives beyond 6 months - executed X-ray or surgery gives beyond 4 weeks - informed Consent written
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Diagnosis of other malignant neoplasma in last the 10 years except the carcinoma in situ of the cervix uterine and the basalioma or spinalioma cutaneous adequately deals to you - Pregnancy or breast-feeding in course - Previous chemotherapy for metastatic disease - Previous chemotherapy with LOHP or Cpt-11 - adiuvante Chemotherapy with fluoropirimidine finished from less than 6 months - X-ray or surgery executed from less than 4 weeks - Morbo di Crohn, colite ulcerosa or other inflammatory disease of the intestine - Colectomia total or ileostomia - Occlusion or internal subocclusione - scompensate metabolic Diseases or infections in action - not controlled cardiac Arrhythmies or ischemic cardiopathy - Infarct acute of the myocardium in last the 2 years - Impossibility to execute adapted follow up.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified